Label: CLONIDINE HYDROCHLORIDE injection, solution

  • NDC Code(s): 70771-1193-1, 70771-1194-1
  • Packager: Cadila Healthcare Limited
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated July 24, 2020

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  • SPL UNCLASSIFIED SECTION

  • PRINCIPAL DISPLAY PANEL

    PRINCIPAL DISPLAY PANEL – 100 mcg/mL Container Label

    NDC 70771-1193-1

    Clonidine Hydrochloride Injection

    1000 mcg/10 mL

    (100 mcg/mL)

    For Epidural Injection

    Rx only

    10 mL Single-Dose Vial

    Zydus pharmaceuticals

    Clonidine Hydrochloride Injection, 0.1mg/mL, vial Label

    PRINCIPAL DISPLAY PANEL – 100 mcg/mL Carton Label

    Rx only

    Zydus pharmaceuticals

    NDC 70771-1193-1

    Clonidine Hydrochloride Injection

    1000 mcg/10 mL

    (100 mcg/mL)

    For Epidural Injection

    10 mL Single-Dose Vial

    Clonidine Hydrochloride Injection, 0.1mg/mL,  Carton Label

    PRINCIPAL DISPLAY PANEL – 500 mcg/mL Container Label

    NDC 70771-1194-1

    Clonidine Hydrochloride Injection

    5000 mcg/10 mL

    (500 mcg/mL)

    For Epidural Injection

    MUST BE DILUTED BEFORE USE

    Rx only

    10 mL Single-Dose Vial

    Zydus pharmaceuticals

    Clonidine Hydrochloride Injection 0.5 mg/mL, Vial Label

    PRINCIPAL DISPLAY PANEL – 500 mcg/mL Carton Label

    Rx only

    Zydus pharmaceuticals

    NDC 70771-1194-1

    Clonidine Hydrochloride Injection

    5000 mcg/10 mL

    (500 mcg/mL)

    For Epidural Injection

    MUST BE DILUTED BEFORE USE

    10 mL Single-Dose Vial

    Clonidine Hydrochloride Injection 0.5 mg/mL, Carton Label
  • INGREDIENTS AND APPEARANCE
    CLONIDINE HYDROCHLORIDE 
    clonidine hydrochloride injection, solution
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1193
    Route of AdministrationEPIDURAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CLONIDINE HYDROCHLORIDE (UNII: W76I6XXF06) (CLONIDINE - UNII:MN3L5RMN02) CLONIDINE HYDROCHLORIDE0.1 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70771-1193-11 in 1 CARTON01/31/2018
    110 mL in 1 VIAL; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20260101/31/2018
    CLONIDINE HYDROCHLORIDE 
    clonidine hydrochloride injection, solution
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1194
    Route of AdministrationEPIDURAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CLONIDINE HYDROCHLORIDE (UNII: W76I6XXF06) (CLONIDINE - UNII:MN3L5RMN02) CLONIDINE HYDROCHLORIDE0.5 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70771-1194-11 in 1 CARTON01/31/2018
    110 mL in 1 VIAL; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20260101/31/2018
    Labeler - Cadila Healthcare Limited (918596198)
    Registrant - Cadila Healthcare Limited (918596198)
    Establishment
    NameAddressID/FEIBusiness Operations
    Cadila Healthcare Limited918596198ANALYSIS(70771-1193, 70771-1194) , MANUFACTURE(70771-1193, 70771-1194)